September 28, 2019
REMEDIAL III Shows UFR-Guided Hydration Reduces Risk of Contrast-Induced Kidney Injury in High-Risk Patients
September 29, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the REMEDIAL III trial were presented by Carlo Briguori, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.
REMEDIAL III was a randomized, multicenter, investigator-initiated trial designed to compare two hydration strategies for reducing the risk of acute kidney injury. Investigators evaluated urine flow rate-guided (UFR) versus left ventricular end-diastolic pressure-guided (LVEDP) hydration in patients at high risk for contrast-induced kidney injury.
As summarized in the CRF announcement, UFR-guided technique was shown to be more effective in preventing complications such as acute kidney injury and/or acute pulmonary edema.
The trial enrolled 708 patients with an estimated glomerular filtration rate ≤ 45 mL/min/1.73 m2 and/or with a Mehran score ≥ 11 and/or a Gurm score > 7. Patients were randomized 1:1 to LVEDP-guided hydration with normal saline (LVEDP-guided group; n = 355), or UFR-guided hydration controlled by the RenalGuard system (RenalGuard Solutions, Inc.; UFR-guided group; n = 353). In all cases, iobitridol (a low-osmolar, nonionic contrast agent) was administered.
The primary endpoint was the composite of contrast-induced acute kidney injury (defined as a serum creatinine increase ≥ 25% and/or ≥ 0.5 mg/dL from the baseline to 48 hours) and/or acute pulmonary edema.
The investigators found that the primary endpoint occurred in 5.7% (n = 20 of 351) of patients in the UFR-guided group and in 10.3% (n = 36 of 351) of patients in the LVEDP-guided group (relative risk = 0.56; 95% confidence interval, 0.39 to 0.79; P = .036).
In the CRF announcement, Dr. Briguori commented, “Acute kidney injury can be a serious complication due to the contrast received during invasive diagnostic or interventional procedures. Hydration is the cornerstone to prevent this complication. However, uncontrolled hydration may lead to acute pulmonary edema. The REMEDIAL III trial compared two tailored hydration regimens to reduce these risks as a whole in high-risk patients. The study found that UFR-guided hydration is superior to LVEDP-guided hydration to prevent acute kidney injury and acute pulmonary edema. The number needed to treat to prevent one event with the RenalGuard system was 22.”